Parkinson DiseaseCANADANCT05402163
CANadian Adaptive DBS TriAl
A study testing Adaptive DBS and Continuous DBS in people with Parkinson Disease, run by University of Toronto at 1 site in Canada.
Trial summary
Parkinsonian symptoms, such as freezing of gait (FOG) or hypophonia, play a significant role in reducing quality of life for Parkinson disease (PD) patients, and are poorly responsive or can worsen with deep brain stimulation (DBS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Adaptive DBS and Continuous DBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PD treated with bilateral STN DBS using Medtronic lead
- Able to provide informed consent and comply with study protocol
- Need to replace the implantable pulse generator (IPG) due to battery end of life
- Presence of disabling gait and/or balance and/or speech issues, as clinically judged by the PI and the patient
- Evidence that these disabling gait and/or balance and/or speech issues are worsened by DBS, i.e. they improve after turning DBS off.
- Use of contact 1 and/or 2 on one hemisphere and/or 9 and/or 10 on the other one
- Good LFP signal (assessable only after IPG replacement with Percept) in at least one hemisphere
Who cannot join
- Previous DBS surgery without Medtronic products
- Potential use of any therapeutic stimulation configuration (such as bipolar) during the study which will prevent the use of aDBS
- Presence of any other disorders potentially impacting the outcome measures (e.g. orthopaedic issues)
- Medically unstable
- Severe non-motor problems, such as depression, dementia, etc.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Movement Disorders Centre - Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Alfonso Fasano, MD, PhD, (416) 603-5800 ext. 5961, alfonso.fasano@uhn.ca
Alexandra Boogers, MBBCh, (416) 603-5800 ext. 3158, alexandra.boogers@uhn.ca
About this study
Official title: Adaptive/Closed Loop vs. Continuous/Open Loop Deep Brain Stimulation of Subthalamic Nucleus: a Two-Phase, Cross-Over, Double-Blind Trial in Patients With Parkinson's Disease
Parkinsonian symptoms, such as freezing of gait (FOG) or hypophonia, play a significant role in reducing quality of life for Parkinson disease (PD) patients, and are poorly responsive or can worsen with deep brain stimulation (DBS). Repeated adjustments of stimulation parameters may be beneficial however, continuous DBS (cDBS) does not adapt to the patients' rapidly fluctuating clinical status and does not take into account reliable and consistent state-trait biomarkers. These biomarkers can be recorded by the electrode itself as local field potentials (LFP). These LFPs can be used to guide stimulation output by means of a 'closed loop' or 'adaptive' DBS (aDBS).
This is a pilot, two-phase, double-blinded, cross-over study of chronic Adaptive vs. Continuous STN DBS in patients with PD by using a novel implantable DBS system that can automatically adjust stimulation parameters based on the patient's clinical condition. The study will test the hypothesis that aDBS stimulation will treat motor fluctuations similarly to continuous stimulation but it will be superior to the latter in the treatment of speech, gait impairment and falls.
- Conditions
- Parkinson Disease
- Being tested
- Adaptive DBS, Continuous DBS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive DBSDevice
aDBS vs cDBS
Continuous DBSDevice
aDBS vs cDBS
| Study group | Role | What they receive |
|---|---|---|
| Continuous DBS | Other | Not described Receives: Device: Continuous DBS |
| Adaptive DBS | Active comparator | Not described Receives: Device: Adaptive DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Activities of Daily Living using the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) II: Motor Aspects of Experiences of Daily Living (M-EDL), range 0-52. Lower scores reflect better motor experience.
Measured: Baseline, 5 months after IPG change, 8 months after battery change
Change in Quality of Life (QoL) using Parkinson's Disease Questionnaire (PDQ39)
Parkinson's Disease Questionnaire (PDQ39): 8 dimensions, 5-point ordinal scoring system, each dimension total score range from 0 to 100. Lower scores reflect better QoL.
Measured: Baseline, 5 months after IPG change, 8 months after battery change
Change in Gait using the Zeno Walkway by Protokinetics
Gait analysis (off and on medication) using the Zeno Walkway by Protokinetics.
Measured: Baseline, 5 months after IPG change, 8 months after battery change
Change in Speech Quality using the Praat software (Phonetic Sciences)
Phonetic speech analysis (off and on medication) using the Praat software (Phonetic Sciences, Amsterdam, The Netherlands). Increased phonation reflects better speech quality.
Measured: Baseline, 5 months after IPG change, 8 months after battery change
Secondary outcomes (1)
Change in Motor Outcomes (adaptive DBS vs continuous DBS arms) using Unified Parkinson's Disease Rating Scale part III (motor examination)
Unified Parkinson's Disease Rating Scale motor examination (MDS-UPDRS III) score, range 0-132. Lower scores reflect less motor impairment.
Measured: Baseline, 2-5 months after IPG change, 8 months after battery change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Jun 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Fasano, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402163
- Sponsor's protocol ID
- 17-5527
- Acronym
- CANADA
- Status last verified
- Jul 2024
- First submitted
- 4 Apr 2022
- Last updated
- 18 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive/Closed Loop vs. Continuous/Open Loop Deep Brain Stimulation of Subthalamic Nucleus: a Two-Phase, Cross-Over, Double-Blind Trial in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05402163
- Acronym / sponsor ID
- CANADA / 17-5527
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parkinsonian symptoms, such as freezing of gait (FOG) or hypophonia, play a significant role in reducing quality of life for Parkinson disease (PD) patients, and are poorly responsive or can worsen with deep brain stimulation (DBS). Repeated adjustments of stimulation parameters may be beneficial however, continuous DBS (cDBS) does not adapt to the patients' rapidly fluctuating clinical status and does not take into account reliable and consistent state-trait biomarkers. These biomarkers can be recorded by the electrode itself as local field potentials (LFP). These LFPs can be used to guide stimulation output by means of a 'closed loop' or 'adaptive' DBS (aDBS).
This is a pilot, two-phase, double-blinded, cross-over study of chronic Adaptive vs. Continuous STN DBS in patients with PD by using a novel implantable DBS system that can automatically adjust stimulation parameters based on the patient's clinical condition. The study will test the hypothesis that aDBS stimulation will treat motor fluctuations similarly to continuous stimulation but it will be superior to the latter in the treatment of speech, gait impairment and falls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous DBS | Other | Device: Continuous DBS |
| Adaptive DBS | Active comparator | Device: Adaptive DBS |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- PD treated with bilateral STN DBS using Medtronic lead
- Able to provide informed consent and comply with study protocol
- Need to replace the implantable pulse generator (IPG) due to battery end of life
- Presence of disabling gait and/or balance and/or speech issues, as clinically judged by the PI and the patient
- Evidence that these disabling gait and/or balance and/or speech issues are worsened by DBS, i.e. they improve after turning DBS off.
Key exclusion criteria (5 listed)
- Previous DBS surgery without Medtronic products
- Potential use of any therapeutic stimulation configuration (such as bipolar) during the study which will prevent the use of aDBS
- Presence of any other disorders potentially impacting the outcome measures (e.g. orthopaedic issues)
- Medically unstable
- Severe non-motor problems, such as depression, dementia, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive DBSaDBS vs cDBS | Device | Adaptive DBS |
| Continuous DBSaDBS vs cDBS | Device | Continuous DBS |
Primary outcome
Change in Activities of Daily Living using the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II
Time frame: Baseline, 5 months after IPG change, 8 months after battery change
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) II: Motor Aspects of Experiences of Daily Living (M-EDL), range 0-52. Lower scores reflect better motor experience.
Change in Quality of Life (QoL) using Parkinson's Disease Questionnaire (PDQ39)
Time frame: Baseline, 5 months after IPG change, 8 months after battery change
Parkinson's Disease Questionnaire (PDQ39): 8 dimensions, 5-point ordinal scoring system, each dimension total score range from 0 to 100. Lower scores reflect better QoL.
Change in Gait using the Zeno Walkway by Protokinetics
Time frame: Baseline, 5 months after IPG change, 8 months after battery change
Gait analysis (off and on medication) using the Zeno Walkway by Protokinetics.
Change in Speech Quality using the Praat software (Phonetic Sciences)
Time frame: Baseline, 5 months after IPG change, 8 months after battery change
Phonetic speech analysis (off and on medication) using the Praat software (Phonetic Sciences, Amsterdam, The Netherlands). Increased phonation reflects better speech quality.
1 secondary outcome
Change in Motor Outcomes (adaptive DBS vs continuous DBS arms) using Unified Parkinson's Disease Rating Scale part III (motor examination)
Time frame: Baseline, 2-5 months after IPG change, 8 months after battery change
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Movement Disorders Centre - Toronto Western Hospital
Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive DBS and Continuous DBS in people with Parkinson Disease, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Activities of Daily Living using the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II (time frame: Baseline, 5 months after IPG change, 8 months after battery change). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.